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欧盟REACH信息要求即将发生的变化
来源:ECHA | 作者:沐睿环境-莉哥 | 发布时间: 2021-09-23 | 340 次浏览 | 分享到:

Upcoming changes to REACH information requirements

ECHA/NR/21/19

The European Commission has revised certain information requirements for registering chemicals under REACH. The changes will start to apply in early 2022 and companies need to start preparing. ECHA will publish more advice in late 2021.

Helsinki, 29 June 2021 - The update of the REACH annexes clarifies the information companies need to submit in their registrations and makes ECHA’s evaluation practices more transparent and predictable. The law comes into effect on 8 July 2021 and will apply from 8 January 2022.

The main changes concern:

  • requirements for surface tension and water solubility of metals and sparingly soluble metal compounds;

  • requirements for in vitro testing for eye irritation and in vivo testing for skin or eye irritation;

  • requirements and adaptations for 28-day and 90-day repeated dose toxicity studies; 

  • specific rules for adapting reproductive toxicity studies; 

  • general rules for adaptation based on: 

    • use of existing data; 

    • weight of evidence;

    • substance-tailored exposure-driven testing; and 

    • grouping of substances – in particular, those of unknown or variable composition, complex reaction products and biological materials (UVCBs);

  • new rules for adapting studies on fate and behaviour in the environment based on a low octanol-water partition coefficient; 

  • new specific rules for adapting for dissociation constant and viscosity; and

  • additional requirements for human health and environmental testing to be performed at appropriately high dose levels.

ECHA is updating its guidance materials and will publish more advice to registrants towards the end of 2021.

REACH信息要求即将发生的变化
ECHA / NR / 21/19
欧盟委员会修订了REACH下化学品注册的某些信息要求。这些变化将于2022年初开始实施,企业需要开始准备。ECHA将在2021年底发布更多建议。
赫尔辛基,2021年6月29日—REACH附件的更新明确了企业在注册时需要提交的信息,并使ECHA的评估实践更加透明和可预测。该法律将于2021年7月8日生效,并将于2022年1月8日生效。
主要变化涉及:
金属和少量可溶金属化合物的表面张力和水溶性要求
眼睛刺激的体外试验和皮肤或眼睛刺激的体内试验的要求;
28天和90天重复剂量毒性研究的要求和适应性;
适应生殖毒性研究的具体规则;
适应的一般规则基于:
使用现有数据;
重量的证据;
substance-tailored exposure-driven测试;和
对物质进行分组,特别是那些成分未知或可变的物质、复杂反应产物和生物材料(UVCBs);
基于低辛醇-水分配系数的适应环境中命运和行为研究的新规则;
解离常数和粘度的新的特殊适应规则和
对在适当高剂量水平下进行的人类健康和环境测试的额外要求。
ECHA正在更新其指导材料,并将在2021年底前向注册人发布更多建议。





更多信息请点击:https://echa.europa.eu/de/home 

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